MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Model Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros creatinine xt (creaxt) result was obtained from a single biorad quality control level using vitros creaxt slide lot 7217-0015-5648 on a vitros xt 7600 integrated system.Biorad control lot 56720 level 1 vitros creaxt result of 1.50 mg/dl vs.The vitros peer mean result of 0.827 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros creaxt result was obtained from a non-patient quality control fluid.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros creatinine xt (creaxt) result was obtained from a single biorad quality control level using vitros creaxt slide lot 7217-0015-5648 on a vitros xt 7600 integrated system.The assignable cause of the event is a suboptimal calibration event.The result was generated from a calibration event performed on 15 january 2024, labeled as cal curve 1748 using calibrator kit lot 0173.The calibration responses and parameters associated with cal curve 1748 were atypical when compared to the expected calibration responses and parameters.The cause of the atypical calibration is unknown.Accurate biorad quality control results were generated using an alternate calibration event performed on vitros creaxt slide lot 7217-0015-5648, using the same calibrator lot.This indicated neither vitros creaxt slide lot 7217-0015-5648 nor the vitros xt 7600 integrated system likely contributed to the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros creaxt slide lot 7217-0015-5648.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18696393
• Report Number: 1319808-2024-00004
• Device Sequence Number: 8424109
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: 10758750000166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 1882208
• Device Catalogue Number: 1882208
• Device Lot Number: 0173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown